QII
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1355
- Medical specialty
- Clinical Chemistry
- FDA definition
- An integrated continuous glucose monitoring system for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.
- Adverse events (MAUDE)
- 2021: 93 · 2022: 59 · 2023: 62 · 2024: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Dexcom G6 Pro Continuous Glucose Monitoring System (K191833) | Dexcom, Inc. | 2019-10-07 |
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